Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta in Healthy Subjects

Trial Profile

Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 15 Oct 2017

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Cinfa Biotech
  • Most Recent Events

    • 04 Oct 2017 According to a Cinfa Biotech media release, based on the data from this and other study (see profile 276855), the European Medicines Agency (EMA) has accepted Marketing Authorisation Application (MAA) for B12019 to treat chemotherapy-induced neutropenia.
    • 12 Sep 2017 Results of this and other study (NCT02912377), presented at the 42nd European Society for Medical Oncology Congress.
    • 06 Dec 2016 Primary endpoint has been met. (PD parameter ANC) as per results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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